Orally consumable pharmaceutical products contain active ingredients for treatment of a wide variety of ailments. The packaging and labeling of such products are heavily regulated to protect the safety of consumers. Specifically, pharmaceutical products are labeled to provide the consumer with accurate information as to the contents of the product. Regulatory bodies worldwide oversee safety in pharmaceutical product labeling. In the United States, the Food and Drug Administration (“FDA”) is responsible for regulating packaging and labeling of pharmaceutical products. Labeling for both prescription and over-the-counter (“OTC”) drug products are regulated by the FDA. In particular, regulations require accurate identification of all active ingredients and their amounts contained in the pharmaceutical product. For instance, for OTC products, actives must be listed in hierarchical order of their relative amounts along with the concentration per unit dosage and pharmaceutical purpose of each.
To comply with such regulations, active ingredient information must be correctly identified on the product labeling. Actives that are complexed with another substance, such as a salt, form a new chemical entity having new and different functionality from the initial uncomplexed active. This new chemical entity is the active ingredient that can be used in a variety of different pharmaceutical products. There is a need to properly identify this new chemical entity as the active ingredient contained in such products. Therefore, accurate drug information can be provided to consumers and governmental regulations can be satisfied.